BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 778672 · Received November 3, 2006

    Report

    Report Number
    9710055-2006-00006
    Event Type
    Other
    Date Received
    November 3, 2006
    Report Date
    October 2, 2006
    Manufacturer
    MAQUET S.A.
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS RETURNED FOR EVALUATION. DETERMINATION WAS MADE THAT THERE WAS ONE EXTRA WASHER INSTALLED BETWEEN MAIN ARM AND SPRING ARM PREVENTING THE C-CLIP FROM SEATING PROPERLY. THIS IS AN ACTIVE OR SETTING AT THIS FACILITY. THIS OR HAS TWO DUAL LIGHT SYSTEMS WITHIN THE ROOM WHICH ALLOWS ACTIVITIES TO CONTINUE UNTIL REPAIRS OR A REPLACEMENT IS INSTALLED. GETINGE USA, INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SA PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FROM THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE OR WAS CLEANED EARLY THAT MORNING. DURING OR PREPARATION AND PRIOR TO ANY PATIENTS BEING IN THE ROOM, ONE OF THE 4000 SERIES LIGHT HEADS SEPARATED BETWEEN THE MAIN ARM AND SPRING ARM. THE SPRING ARM AND LIGHT HEAD ASSEMBLY FELL TO THE FLOOR. NO ONE WAS HIT BY THE FALLING LIGHT HEAD OR SPRING ARM. NO INJURIES ARE REPORTED; JUST DAMAGED PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM SURGICAL LAMP FQP MAQUET S.A. PRX4401 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN